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Completed

NCT Number: NCT02683122

The DIPOD Study (Diagnosis Improvement of Pneumonia by Organ Dysfunction)

The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined.

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Key information

Conditions

Pneumonia, Ventilator-Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

About this study

New onset of pulmonary infiltrates, fever, and an increase in white blood cell (WBC) count accompanied by purulent tracheal secretions are clinically indicative of hospital-associated pneumonia (HAP). The low specificity and sensibility of diagnostic tests for HAP, however, tends to result in an extremely high incidence of missed diagnoses and may lay to high mortality.

The place of analysis of organ dysfunction in relation to the diagnosis of nosocomial pneumonia in intensive care is not yet defined, because early organ dysfunction may be the first symptoms noted by clinicians.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients after cardiac/thoracic surgery with suspicion of HAP defined by the presence of the following criteria:

  • new onset of pulmonary infiltrates,
  • fever >38,3°C,
  • increase in white blood cell (WBC) count
  • purulent tracheal secretions
  • but also:
  • increased use of catecholamine,
  • need of volemic expansion,
  • depletion inability,
  • confusion,
  • hepatic perturbation with increased gamma-glutamyl transpeptidase (GGT)>2N or alkaline phosphatase (ALP) >1.5 N, or bilirubin >1.5N, or aminotransferase (AST or ALT>2 N).

Exclusion criteria

  • child,
  • pregnancy,
  • end of life.

Treatment and study plan

Primary outcomes

  1. Area under the ROC curve of the CPIS score

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

    The CPIS score is based on six variables:

    • Fever
    • Leukocytosis
    • Tracheal aspirates
    • Oxygenation
    • Radiographic infiltrates
    • Cult of tracheal aspirates

Secondary outcomes

  1. Area under the ROC curve of increased use of catecholamine and their positive and negative predictive values

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

    Sensibility (%) and specificity (%) increased use of catecholamine

  2. Area under the ROC curve of increased need a volemic expansion and their positive and negative predictive values

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

    Sensibility (%) and specificity (%) increased need a volemic expansion

  3. Area under the ROC curve of depletion inability and their positive and negative predictive values

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

    Sensibility (%) and specificity (%) of depletion inability

  4. Area under the ROC curve of confusion and their positive and negative predictive values

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

    Sensibility (%) and specificity (%) of confusion

  5. Area under the ROC curve of hepatic perturbation and their positive and negative predictive values

    Time frame: the previous 12 hours up to performance of pulmonary bacteriological samples

    Sensibility (%) and specificity (%) of hepatic perturbation defined by increased gamma-glutamyl transpeptidase (CGT) and or alkaline phosphatase >1,5 N and or bilirubin >1,5 N or aminotransferase (AST or ALT >2 N)

  6. Mortality

    Time frame: 28 days

    Mortality during ICU stay

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Official study title

Improvement of Diagnosis of Hospital Acquired Pneumonia (HAP) Based on Early Organ Dysfunction

Acronym: DIPOD

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2016
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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